1. Regulation on introducing process of the highly difficult new medical technologies: A survey on the current status of practice guidelines in Japan and overseas.
- Author
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Minamikawa K, Okumura A, Kokudo N, and Kono K
- Subjects
- Biomedical Technology legislation & jurisprudence, Clinical Competence, Delivery of Health Care organization & administration, Hospital Administration legislation & jurisprudence, Hospital Administration standards, Hospitals statistics & numerical data, Humans, Informed Consent standards, Japan, Legislation, Hospital standards, Legislation, Hospital statistics & numerical data, Patient Safety, Postoperative Complications etiology, Postoperative Complications prevention & control, Practice Guidelines as Topic, Surgeons legislation & jurisprudence, Surgeons standards, Surgical Procedures, Operative adverse effects, Surgical Procedures, Operative legislation & jurisprudence, Surgical Procedures, Operative methods, Surgical Procedures, Operative standards, Surveys and Questionnaires statistics & numerical data, Biomedical Technology standards, Delivery of Health Care standards, Diffusion of Innovation, Hospitals standards
- Abstract
Since serious problematic cases regarding the technical safety of technically demanding operations were reported in Japan, the Ministry of Health, Labor and Welfare issued new regulations on June 10, 2016 requiring each hospital to check the status of informed consent, skill of surgery team and governance system of the surgical unit, when the highly difficult new medical technologies were introduced to a hospital. In order to firmly establish this new system for highly difficult new medical technologies, it is very important and informative to survey the current situation for guidelines and consensus regarding introduction of medical technology with special skills in Japan and overseas. Based on the survey of questionnaires, document retrieval, and expert interviews, we found that documentation related to the introduction process of highly difficult medical technologies is very rare, and the regulations were mainly issued by academic societies. Moreover, even if such documentation existed, the quality of the regulations is poor and not sufficient enough to perform surgical practice safely. Therefore, for medical practitioners, comprehensive and concrete regulations should be issued by the government or ministry to legally follow in regard to technically demanding operations. A new practice guideline was proposed by our special research group to regulate the introduction process of highly difficult new medical technologies in hospitals in Japan. This guideline, gained understanding from relevant academic societies, provided a comprehensive view on the interpretation of "high difficulty new medical technology" prescribed by the law and show the basic idea at a preliminary examination from the viewpoints of "Surgeon's requirement", "Guidance system", "Medical safety" , and "Informed consent". These efforts will contribute to the improvement of the quality of guidelines regarding "highly difficult new medical technology".
- Published
- 2019
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